Acute Respiratory Distress Syndrome (ARDS)
Conditions
Brief summary
People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.
Detailed description
Introduction: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) requires mechanical ventilatory (MV) life support. In this scenario, lung protective strategies have been recommended for avoiding ventilator induced lung injuries mainly by inappropriate positive end expiratory pressure (PEEP) titration. However, the best method of PEEP titration for these patients remains unclear, since its clinical and morphofunctional phenotype may differ from the conventional acute respiratory distress syndrome (ARDS) phenotype resulted from other etiologies. In addition, these patients' condition of long lasting MV dependency and bed restriction may lead to deterioration of respiratory and peripheral muscles functions. Objective: To compare the clinical and laboratory evolution and the respiratory and peripheral muscle functions in mechanically ventilated patients with COVID-19 submitted to PEEP titration by the following methods: ARDSNet protocol, driving pressure (DP) and electrical impedance tomography (EIT), as well as following them up after hospital discharge. Methods: This is a controlled, randomized, double blind clinical trial with 90 mechanically ventilated patients to be randomized in one of the 3 PEEP titration- related groups: ARDSNet protocol, Driving Pressure-DP (electing PEEP level by the lowest DP) and by the EIT (PEEP selected will be the closest level above the intercept point of cumulated collapse and overdistension percentage curves). Clinical, laboratory, oxygenation, ventilation, respiratory and regional mechanics data, as well as peripheral muscle outcomes (strength and functionality) will be monitored from intubation to extubation in the supine and prone position. The outcomes of respiratory and peripheral muscles functionality will be monitored for six months after hospital discharge. All ethical principles will be respected with either written Free and Consent Term by the patient or relatives at the intensive care phase or at the post ICU discharge phase. Data will be registered for posterior analysis, which considers the difference between groups with p \<0.05. Expected results: Based on this study, it is expected to identify the Peep titration method associated to the greater beneficial and less deleterious effects in critically ill patients on MV. Also to address appropriate lung protective ventilation strategy for these patients and to detect respiratory and peripheral muscle disorders as early as possible in critically ill survivors.
Interventions
OTHERARDSNet table
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
OTHERDriving Pressure
The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.
OTHERElectrical Impedance Tomography
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
Sponsors
Universidade Federal de Pernambuco
Coordination for the Improvement of Higher Education Personnel
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Ciência e Tecnologia de Pernambuco
University of Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
trial participants, data collectors and outcome assessors or committees will remain blinded to the patient assigned group of treatment.
Intervention model description
three groups of treatments (A, B and C) are given so that one group receives only A while another group receives only B and the third group receives only C. All volunteers will be randomized to one of the three groups of treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mechanically ventilated patients due to acute respiratory failure associated to COVID-19 confirmed or suspected cases
Exclusion criteria
* consent refusal by patient, family or doctor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Murray Score (LIS) | 4 hours | Scoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome. |
| Potential lung recruitment measured during electrical impedance tomography | 4 hours | to quantify lung ventilation distribution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation (MV days) | Through study completion, an average of 1 year | to quantity the number of days with use of invasive mechanical ventilation in inpatients. |
| ICU Mortality | Through study completion, an average of 1 year | to quantify number of living days between ICU admission and deceased status |
| respiratory muscle strength | Through study completion, an average of 1 year | maximal static respiratory mouth pressures |
| Forced vital capacity (FVC) measured during spirometry | Through study completion, an average of 1 year | measures obtained by spirometry in outpatients |
| diaphragmatic mobility measured during ultrasonography | Through study completion, an average of 1 year | diaphragmatic excursion expressed in millimeters |
| diaphragmatic thickening measured during ultrasonography | Through study completion, an average of 1 year | diaphragmatic thickening expressed in millimeters |
| breathing pattern measured during airway flowmeter | Through study completion, an average of 1 year | a device to quantify airway flow |
| Length of days in intensive care unit (ICU days) | Through study completion, an average of 1 year | to quantify the number of days spent in a critical care unit |
| peripheral muscle strength II | Through study completion, an average of 1 year | to be evaluated by a handgrip dynamometers in outpatients |
| peripheral muscle strength III | Through study completion, an average of 1 year | to be evaluated by a handheld dynamometer in outpatients |
| six-minute walk test (6WT) | Through study completion, an average of 1 year | sub-maximal exercise test used to assess aerobic capacity and endurance in outpatients |
| functional capacity (Perme scale) | Through study completion, an average of 1 year | The minimum score is 0 and the maximum is 32. The higher the score, the better outcome. |
| daily activities performance | Through study completion, an average of 1 year | to be evaluated by Barthel Index in outpatients |
| quality of life measured by Short Form Health survey 36 | Through study completion, an average of 1 year | score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| peripheral muscle strength I | Through study completion, an average of 1 year | to be evaluated by Medical Research Council's scale. The minimum score is 0 and the maximum is 60. The higher the score, the better outcome. |
| Work of breathing (WOB) measured during surface electromyography | 4 hours | measured in root-mean-squared electromyography signals |
Countries
Brazil
Outcome results
None listed